Tipifarnib is an inhibitor of farnesylation, a key cell-signaling process implicated in cancer initiation and development. In early trials, tipifarnib has shown compelling and durable anticancer activity in certain patients.

“Prior to our experience, tipifarnib was studied in more than 5000 patients and although it demonstrated compelling anticancer activity in some cases, no molecular target was identified that could explain such activity,” explained Antonio Gualberto, MD, PhD, head of development and chief medical officer of Kura Oncology, in a prepared statement. “This registration-directed trial implements the many learnings from our clinical experience in patients with HNSCC. We believe we can now identify those patients most likely to receive clinical benefit from tipifarnib. If successful, we believe this registration-directed trial could bring a much-needed treatment option to patients with HRAS mutant HNSCC.”

The trial will include 2 cohorts, a treatment cohort (AIM-HM) and a noninterventional screening and outcomes cohort (SEQ-HN).

The AIM-HM cohort will enroll at least 59 patients with HRAS-mutant HNSCC who had had prior platinum-based treatment. Included patients are required to have HRAS mutant allele frequency of at least 20%. The trial will start patients at 600 mg oral tipifarnib twice daily. The primary end point is objective response rate.

The second cohort — SEQ-HN — will match patients with recurrent or metastatic HNSCC with HRAS mutations with those who are HRAS-wild-type. The researchers hope that SEQ-HN will provide a better understanding of the natural history of patients with HRAS mutations and help to identify patients for potential enrollment into AIM-HN.

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